Journal article

Interpretation of clinical studies in electronilysiology: statistical considerations for the clinician

David Chieng, Sue Finch, Hariharan Sugumar, Andrew J Taylor, Chris Reid, Jonathan M Kalman, Peter M Kistler

EUROPACE | OXFORD UNIV PRESS | Published : 2021

Abstract

Atrial fibrillation (AF) outcome studies play an essential role in the development of clinical evidence to improve the management of AF patients. Understanding the statistical considerations involved in study design and interpretation is crucial if electrophysiologists are to change practice. In this review, with the guidance of a medical statistician and a clinical trialist we provide an overview of important statistical issues for the clinician, with a focus on clinical studies in AF ablation. Various types of study designs including randomized controlled trials, superiority, and non-inferiority studies are described, along with their implications and limitations. Appropriate sample size c..

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